INDICATIONS

Premarin is a mixture of estrogen hormones used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Premarin is sometimes used as part of cancer treatment in women and men. Premarin should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

INSTRUCTIONS

Use Premarin as directed by your doctor.

• Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.
• Premarin is taken on a daily basis. For certain conditions, Premarin is given in a cycle, such as 25 days on followed by 5 days. Follow the directions on your prescription label.
• Premarin may be taken by mouth with or without food.
• Take Premarin with a full glass of water.
• Try to take the medicine at the same time each day.
• Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Premarin.
• It is important to take Premarin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
• To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.
• If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Premarin. You may need to stop using the medicine for a short time.
• This medication can affect the results of certain medical tests. Tell any doctor who treats you that you are using Premarin.
• If you miss a dose of Premarin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Premarin.

STORAGE

Store Premarin between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed, light-resistant container. Store away from moisture, heat, and light. Do not store in the bathroom. Keep Premarin out of the reach of children and away from pets.

Premarin (conjugated estrogens tablets) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares’ urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17О±-dihydroequilin, 17О±- estradiol, and 17ОІ-dihydroequilin.

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Premarin tablets also contain the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, and titanium dioxide.

Do NOT use Premarin if:

• you are allergic to any ingredient in Premarin
• you are pregnant or suspect you may be pregnant
• you have a history of known or suspected breast cancer (unless directed by your doctor) or other cancers that are estrogen-dependent
• you have abnormal vaginal bleeding of unknown cause
• you have liver problems or liver disease, or the blood disease porphyria
• you have recently (within the last year) had a stroke or heart attack
• you have blood clots or circulation disorders.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Premarin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have an abnormal mammogram
• if you have asthma (wheezing), a benign breast nodule, bone cancer, depression, diabetes, endometriosis or endometrial (uterine) cancer, epilepsy (seizures), gallbladder disease, heart problems, high blood pressure, kidney problems, liver problems or a history of yellowing of the skin or eyes, lupus, migraines, obesity, pancreatitis, uterine fibroids, thyroid problems or have high calcium levels in your blood
• if you use tobacco, you are going to have surgery, or you will be on bed rest
• if you have a personal or family history of high cholesterol, lipid, calcium, or triglyceride levels; or breast cancer.

Some medicines may interact with Premarin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Hydantoins (eg, phenytoin) or rifampin because they may decrease Premarin’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Premarin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Premarin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Premarin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
• Smoking while taking Premarin may increase your risk of blood clots (especially in women older than 35 years of age).
• Before using Premarin, you will need to have a complete medical and family history exam, which will include blood pressure, breast, stomach, and pelvic organ exams and a Pap smear.
• You should have periodic mammograms as determined by your doctor. Follow your doctor’s instructions for examining your own breasts, and report any lumps immediately.
• If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.
• Diabetes patients – Premarin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Premarin may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Premarin.
• Premarin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Premarin.
• Lab tests, including a lipid profile, may be performed while you use Premarin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Premarin may affect growth rate in children and teenagers in some cases. They may need regular growth checks while they use Premarin.
• Pregnancy and breast-feeding: Do not use Premarin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Premarin is found in breast milk. If you are or will be breast-feeding while you use Premarin, check with your doctor. Discuss any possible risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal bleeding from the vagina; breast lumps; changes in vision or speech; chest pain; confusion; dizziness; fainting; hoarseness; mental/mood changes; one-sided weakness; pain or tenderness in the upper abdomen; pain or tenderness in the calves; severe headache; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

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